B7-H3 CAR-T for Recurrent or Refractory Glioblastoma

Documented informed consent of the participant and/or legally authorized representative.Histologically confirmed diagnosis of World Health Organization (WHO) classification grade IV glioblastoma (GBM). Clinical Pathology confirms B7-H3 positive tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score >= 50). Relapsed/refractory disease confirmed by radiographic evidence after standard therapy. Suitable for the surgery of the placement of the Ommaya catheter. Eastern Cooperative Oncology Group (ECOG) =0 or 1 (need to be confirmed before intratumoral or intracerebroventricular injection) >= 8 weeks after completion of front-line radiation therapy >= 6 weeks after completion of nitrourea chemotherapy >= 14 days after completion of Temozolomide or other chemotherapy 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline (4 weeks for Bevacizumab). Patients with other chronic AEs are in the investigator's judgement Blood cell count： White blood count (WBC) >= 2000/μL；Neutrophil count >= 1500/μL；Platelets >= 100 x 103/μL；Hemoglobin >= 9.0 g/dL Serum Creatinine <= 1.5×ULN or Creatinine Clearance Rate (Cockcroft and Gault) > 30 mL/min/1.73 m2 Alanine Transaminase (ALT) <= 5×ULN and total bilirubin < 2.0mg/dL Lung function: Oxygen (O2) saturation >= 92% on room air and < CTCAE grade 1 dyspnea Heart function: Left ventricular ejection fraction (LVEF) >= 40% by multigated acquisition (MUGA) scan or echocardiogram Normal coagulation function: prothrombin time (PT)，activated partial thromboplastin time (APTT) and international normalized ratio (INR) Good blood vessel condition for leukapheresis Women of childbearing potential (WOCBP): negative urine or serum pregnancy test Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity within one year after B7-H3 CAR-T infusion